Staff Device Quality Engineer

Key Responsibilities

• Technical Leadership & Strategy
• Standards Execution
• SDLC Architecture & Support
• Agile Integration
• Quality Systems Ownership
• Design Quality & Risk Management
• Design Reviews
• Risk Analysis
• V&V Strategy & Execution
• Execution & Compliance
• DHF Program Ownership
• Audit Leadership
• Cross-Functional Collaboration & Leadership
• Technical Documentation
• Team Development & Mentorship
• Thought Leadership

Skills Needed

• Strong critical thinking skills and great attention to detail.
• Ability to work as a self-starter in a fast-paced, adaptive environment.
• Excellent communication, documentation, and time management skills.
• Demonstrated ability to influence without authority and drive alignment across engineering, regulatory, and product leadership.
• Deep expertise in quality systems strategy, including QMS architecture and CAPA program design for SaMD organizations.

Educational Requirements & Work Experience

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required.
• Master’s degree in a relevant technical or quality discipline preferred.
• 10+ years of experience in quality engineering or product development within the medical device industry, including at least 3 years in a senior or lead quality engineering role for SaMD or AI/ML-enabled products.
• Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Black Belt.